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NCT Number: NCT01745796

Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia (PYO GEN)

Pseudomonas aeruginosa is the main pathogen of nosocomial respiratory infections. Its increasing resistance to antibiotics requires the development of new strategies for prevention and control, demanding a better understanding of the modes of transmission and evolutionary dynamics of this bacteria. In patients under invasive mechanical ventilation, the main mode of contamination by Pseudomonas remains debated, with 3 modes of contamination (endogenous, crossed transmission between patients, or environmental origin) of varying importance, mainly depending on the endemic situation of the place of study.

The emergence of new genotyping technologies (DiversiLab) can now facilitate studies of molecular epidemiology. Thanks to the multidisciplinary collaboration and innovative techniques, the investigators wish to study the impact of the mode of contamination on the outcome of ICU patients, intubated and ventilated for more than 72 hours.

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Key information

Conditions

Pseudomonas Aeruginosa Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Pseudomonas Infections Ventilation Acquired Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical ICU of Universitary Hospital of Grenoble

Grenoble, Isère, 38700, France

About this study

The presence of environmental reservoirs can cause infections and multidrug-resistant P. aeruginosa colonization with P. aeruginosa is itself a prognostic factor, but the impact of the route of infection on the evolution of the history and future of the infectious patient is not established.

A second factor that may influence the evolution infectious is the degree of genetic heterogeneity of the bacterial population. Multiple exposure pathways could also influence the genetic diversity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients> 18 years
  • hospitalized in the intensive care unit
  • with more than 72 hours of mechanical ventilation
  • Presenting a positive bacteriological sample P. aeruginosa.

Exclusion criteria

  • Minors.
  • Pregnant or lactating women.
  • Patients under guardianship, under judiciary placement, or hospitalized without their consent.
  • Patients not affiliated to a social security scheme.
  • Long-term corticosteroid therapy (> 2mg/kg or> 1 month before the onset of established infection suspected)
  • Ongoing chemotherapy, AIDS, transplant patient under immunosuppressive drugs.
  • Bedridden patient or therapeutic decision at ICU arrival

Treatment and study plan

Primary outcomes

  1. The occurrence of unfavorable patient's outcome, depending on the mode of contamination, such as persistence, relapse or superinfection of the airways at Day 7, and mortality at Day 28

    Time frame: From day 3 of intubation until the end of mechanical ventilation (an average of 28 days).

Secondary outcomes

  1. Number of different clones of P. aeruginosa found in each sample analyzed for the same patient at diagnosis of colonization and VAP.

    Time frame: From day 3 of intubation until the end of mechanical ventilation (an average of 28 days).

    Samples of infected patients are analyzed once a week, strains are considered from different clones if their genetic homology rate is below 97%

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia

Acronym: PYO GEN

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2012
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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